Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-0366-2008 | Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on... | Philips North America LLC | JAK | ||
| Z-0323-2008 | Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0322-2008 | Terumo Advanced Perfusion System, 1 Roller Pump, 6 inch diameter; Catalog No. 801041... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0321-2008 | Terumo Advanced Perfusion System, 1 Roller Pump, 4 inch diameter; Catalog No. 801040... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-2201-2008 | Pacific Consolidated Industries Mobile Oxygen Storage Tank, MOST 20-2B, Part Number... | Pacific Consolidated Industries LLC | CAW | ||
| Z-1845-2011 | CellQuest Pro SW, version 4.0.2. and later; Becton Dickinson, San Jose, CA... | Becton, Dickinson and Company, BD Biosciences | GKZ | ||
| Z-1562-2008 | BD DifcoTM Neisseria Meningitidis Antiserum Group Y 241113, 1mL, in vials, which were... | Lee Laboratories, Inc. | GTJ | ||
| Z-1561-2008 | BD DifcoTM Neisseria Meningitidis Antisera Group Y 241113, 1mL, in vials, which were... | Lee Laboratories, Inc. | GTJ | ||
| Z-1560-2008 | BD DifcoTM Neisseria Meningitidis Antisera Group Y 228811, 1mL, in vials, which were... | Lee Laboratories, Inc. | GTJ | ||
| Z-1559-2008 | BD DifcoTM Neisseria Meningitidis Antisera Group Y, 228811, 1mL, in vials, which were... | Lee Laboratories, Inc. | GTJ | ||
| Z-0570-2008 | BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X... | Becton, Dickinson and Company, BD Biosciences | GKZ | ||
| Z-0617-2008 | Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Hill-Rom, Inc., Batesville, IN 47006 | Hill-Rom Inc. | HDD | ||
| Z-0300-2008 | Ventana Medical System's Symphony Staining System, KPA, Model #: 2200000, Catalog #... | Ventana Medical Systems Inc | KEY | ||
| Z-0376-2008 | Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for... | Cepheid | NJR | ||
| Z-0147-2008 | ARCHITECT c16000 Processing Module, for In Vitro Diagnostics; List Number 3L77-01... | Abbott Medical | JJE | ||
| Z-0146-2008 | ARCHITECT c8000 Processing Module, for In Vitro Diagnostics; List Number 106-01; Affected... | Abbott Medical | JJE | ||
| Z-0065-2008 | Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit... | Bio-Rad Laboratories Inc. | LOM | ||
| Z-0115-2008 | Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular... | Zimmer GmbH | LXH | ||
| Z-0143-2008 | Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #... | Medtronic Sofamor Danek USA Inc | MJO | ||
| Z-0142-2008 | Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog... | Medtronic Sofamor Danek USA Inc | MJO | ||
| Z-0141-2008 | Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #... | Medtronic Sofamor Danek USA Inc | MJO | ||
| Z-0140-2008 | Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #... | Medtronic Sofamor Danek USA Inc | MJO | ||
| Z-0139-2008 | Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #... | Medtronic Sofamor Danek USA Inc | MJO | ||
| Z-0138-2008 | Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #... | Medtronic Sofamor Danek USA Inc | MJO | ||
| Z-1155-2008 | GE LOGIQ 3 Expert ultrasound scanner with software versions 4.0.5, 4.1.1 and 4.1.2. GE... | GE Healthcare Clinical Systems | IYN | ||
| Z-0136-2008 | DRL System Trays comprised of DRLock Bone Fixation Plates, Pegs, and Screw Systems: Four... | TORNIER Inc. | HRS | ||
| Z-0062-2008 | HeartStart XL Defibrillator/Monitor, Model: M4735A | Philips North America LLC | MKJ | ||
| Z-0114-2008 | Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil, sterile... | Warsaw Orthopedic, Inc. | GEI | ||
| Z-0522-2008 | life+cel, Replacement battery for Cardiac Science FirstSave Survivalink; OEM... | Exocomm Tech Grp | MKJ | ||
| Z-0521-2008 | life+cel Replacement Battery for Cardiac Science Powerheart AED G3 OEM P/N: 9146-001... | Exocomm Tech Grp | MKJ | ||
| Z-0123-2008 | Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm Left-Interlok, For Cemented Use... | Zimmer GmbH | JWH | ||
| Z-0289-2008 | A1CNOW+ with sampler 10-Test Kits (Product No: 3022), Metrika, Inc., Sunnyvale, CA... | Metrika, Inc. | LCP | ||
| Z-0454-2009 | Vidiera NsP Nucleic Sample Preparation, Part Number: A22421, Version 1.0.41 | Siemens Healthcare Diagnostics Inc. | JQW | ||
| Z-0218-2008 | Texium Closed Male Luer (CML), Model Number 10012241, Cardinal Health, SanDiego, CA. | CareFusion 303, Inc | FPA | ||
| Z-0073-2008 | HA Solid Back Acetabular Shell; Arc Deposited HA Coated Included Dome hole Plug; Hip... | Howmedica Osteonics Corp | MEH | ||
| Z-0072-2008 | Trident PSL HA Cluster Acetabular Shell; Arc Deposited HA Coated Cluster Screw Holes... | Howmedica Osteonics Corp | MEH | ||
| Z-0459-2008 | Roche Diagnostics LightCycler Capillaries (100uL) for use in conjunction with the... | Roche Diagnostics GmbH | JJF | ||
| Z-2403-2010 | Mattress Model 5185 and 5185XL. Manufactured by: Invacare Corp., 2101 East Lake Mary... | Invacare GmbH | FMW | ||
| Z-0254-2008 | NEMIO XG Ultrasound System, Model SSA-580A , Software versions: VI .5.0, Vl .5.000A, VI... | Canon Medical Systems USA, Inc. | IYN | ||
| Z-0253-2008 | NEMIO Ultrasound System, Model SSA-550A , Software versions: V3.1.000B, V3.5.0... | Canon Medical Systems USA, Inc. | IYO | ||
| Z-0063-2008 | Medtronic Export XT Aspiration Catheter, 6F (US) Medtronic Export XT Aspiration Catheter... | Medtronic, Inc. | DQA | ||
| Z-0118-2008 | Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm... | Boston Scientific Corporation | FFF | ||
| Z-0117-2008 | Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm... | Boston Scientific Corporation | FFF | ||
| Z-0116-2008 | Boston Scientific Radial Jaw Large Capacity Biopsy Forceps, Sterile, 240 mm. Box of 20 U... | Boston Scientific Corporation | FFF | ||
| Z-0081-2008 | Medtronic Paceart System, 2006 Edition, Medtronic, Inc. 710 Medtronic Parkway... | Medtronic, Inc. | DPS | ||
| Z-0524-2008 | life+cel, Replacement battery for Cardiac Science FirstSave Survivalink,Lithium Sulfur... | BatteryZone, Inc. | MKJ | ||
| Z-0523-2008 | life+cel, Replacement Battery for Cardiac Science Powerheart AED G3, Lithium Sulfur... | BatteryZone, Inc. | MKJ | ||
| Z-0074-2008 | Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sagittal Adjusting Screw Implants... | Medtronic Sofamor Danek USA Inc | KWP | ||
| Z-0056-2008 | Angiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO. | Mallinckrodt, Inc. | DXT | ||
| Z-1555-2011 | Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2 A user interface of rthe SL/SLi Series Linear... | Elekta Limited | IYE |